Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04873713 |
| Other study ID # |
12409331 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 4, 2021 |
| Est. completion date |
July 4, 2021 |
Study information
| Verified date |
February 2024 |
| Source |
Clínica Dr. Francisco Selva |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The tape will be applied on the lumbar area bilateralemten to the spine without creating any
tension.
The possible variation in the range of motion in internal hip rotation is measured with the
KInovea program. A kinesiology tape was used as a placebo tape and the magnetic tape was used
in a randomized experimental way.
Description:
A triple-blind cross-sectional observational study is designed where subjects with low back
pain will be selected and blinded to receive the Magnetic Tape® (tape with magnetic effects
of less than 2 Gauss) or placebo Tape. Likewise, the evaluator who puts the Magnetic Tape®
does not know what material he is using, as it is supplied by another researcher. The patient
does not know what tape will be placed on him.
The recommendations of the "Consolidated Standards of Reporting Trials" (CONSORT) will be
followed. All participants will receive a participant information sheet and sign informed
consent. Patients aged 18 to 65 years with low back pain will be recruited from different
private clinics in the city of Valencia, Spain.
The hypothesis is that when Magnetic Tape® comes into contact with electromagnetic fields
such as those generated by living beings, due to the movement of electrical charges (ions),
as defined by Ampere's Law, the domains of the tape are oriented or aligned in parallel with
the external magnetic field creating a magnetic flux with a north pole and a south pole. This
generated field in turn produces a magnetic induction proportional to the variation of the
magnetic flux, as defined by the Faraday Law.
This electric potential produces a redistribution of the electric charge (ions) generating a
magnetic field due to the orientation of the tape domains, then exerting a force on the
moving charges within the electrolyte.
Physiological, Lorentz's Law, regulating Magnetic Tape® aberrant electromagnetic fields.
The protocol for data collection will be as follows:
After signing the informed consent and data protection, the groups with low back pain will be
formed that will receive the application of both Magnetic Tape® and the intervention of a
placebo tape. To avoid that the order of the intervention influences the results of the
study, the subjects will be randomized into two different groups, Group A and Group B. Group
A will receive Magnetic tape® and Group B will do the opposite. The next day the other tape
will be applied Passive joint ROM of both hips is assessed by placing the patient in a supine
position with 90º hip and knee flexion, performing passive internal hip rotation. The video
camera is located perpendicular (ceiling) to the ipsilateral knee and hip to make recordings
and measurements.
The tapes will be placed on the paravertebral skin from L1 to L5 without creating tension.
Subsequently, both hips are assessed again, performing passive internal hip rotation again
and recording the degrees of range of motion.
Each subject will be your control since one day a tape will be placed and the next day the
other.
Neither application has to be painful.
